Institutional Review Board

The University's Institutional Review Board (IRB) is charged by the University President with the responsibility of reviewing research proposals for the purpose of protecting the rights of individuals who are subjects of any research, conducted by faculty, staff, or students of Simmons University. Federal Regulations place responsibility on the University and the Principal Investigator to insure that high ethical standards are maintained for all research involving human subjects. Simmons University provides education through a web based training program in human research subjects' protections—CITI Program.*

* Information about the CITI Program may be found below.

What is the Simmons University Policy on the protection of human subjects?

In accordance with federal regulations, all research involving human subjects conducted at Simmons University or conducted by Simmons University faculty, staff, or students must be reviewed and approved by the University's Institutional Review Board (IRB).

For definitions of human subjects research and guidelines regarding the types of projects requiring IRB review, please read the the following -What constitutes "human subjects research," subject to IRB review?

Why is this policy important?

Federal regulations mandate that all research involving human subjects be formally approved by the Institutional Review Board (IRB). If this policy is not complied with the University is at risk for losing its federal funding including funding of student programs (e.g., federal financial aid to students).

Review of research by the IRB maintains ethical standards for the conduct of research by protecting subjects, investigators and the University. This policy has been endorsed by the President's Council.

How does this policy affect me?

This policy applies to all Simmons University faculty, students, and staff who are conducting research as defined above. Specifically, all research conducted as part of class requirement is subject to this policy, as is any research conducted by faculty or staff, with or without outside collaborators.


If you have questions about the types of projects requiring review by the IRB, what forms to use, and CITI training please direct them to Valerie Beaudrault, Human Protections Administrator - or 617-521-2415. 

NOTE: Nursing@Simmons students should first contact Professor Patricia Rissmiller ( with their questions regarding the submission of IRB protocols.

What is the Role of the Simmons University IRB?

The IRB is fulfilling a federally mandated function.

  • The IRB reviews projects for their risk/benefit ratio to human subjects. While our role is not one of scientific merit review, this is taken into consideration when assessing risk/benefit.
  • The IRB will work with researchers to develop proposals.
  • The IRB provides education to the Simmons community about human research subjects' protections.

Simmons University is providing education through a web based training program in human research subjects' protections—CITI Program.

CITI Training Program

CITI Program - Web based Training in Human Research Subjects' Protections

Beginning September 1, 2010, the Simmons University Institutional Review Board (IRB) will require all individuals conducting research involving human subjects through the University to complete the CITI (Collaborative Institutional Training Initiative) Program, a web-based human subjects research investigator education program and include their certificate of completion in their IRB packet.

The Simmons University IRB has defined the curriculum for this course, in accordance with your role in Human Subjects Research.

Student Researchers conducting not more than minimal risk research must complete 3 Social and Behavioral Research training modules and 1 elective. Other researchers and students involved in more than minimal risk research must complete 8 Social and Behavioral Research training modules, plus 1 elective

Researchers will have to register with CITI Program and sign in to complete the modules and take the quiz at the end of each session. If you affiliate with other institutions that use CITI, our program compares the modules you need for Simmons with the ones you've already completed elsewhere and will prevent duplication of efforts. It will direct you to only the remaining modules that need to be completed.

CITI Registration Instructions (Please read completely and carefully.)

For new users, below is the link for registering CITI system. Please affiliate yourself with Simmons.

You must select a course and a learner group. You want to select the Human Subjects Research Courses course and then choose the appropriate learner group level.

Student Researchers who are conducting minimal risk research should choose Students. Students must complete the 3 required modules plus 1 elective module to generate a certificate of completion.

Other Researchers, such as faculty, and students involved in more than minimal risk research should select Social & Behavioral.

Do NOT select the Responsible Conduct of Research (RCR) course, unless you have been specifically asked to do so.

Register with the CITI Program.

Click on the 'How do I register?' link under Help & Support for detailed instructions on how to register.

If you have already registered and thus have a user name and password access the CITI training.

Frequently Asked Questions

What constitutes human subjects research?

You are conducting research any time you systematically and purposefully obtain information by asking questions of and/or observing people in order to gather data for the purpose of generating knowledge. This definition applies to a classroom assignment, paper, presentation, pilot study, research project, thesis, or dissertation.

What is a human subject?

A human subject is defined as any living person. Research involving laboratory animals is approved and monitored by the University's Animal Care and Use Committee.

How does the IRB evaluate studies conducted for a class assignment?

A study is considered a "student class project," if it is a systematic investigation that students conduct as assignments designed to teach human research methods, where the results and data are not being disseminated outside of the classroom. This excludes all faculty research and any graduate research relating to thesis or dissertation.

Class projects cannot involve the following participants: institutionalized persons, persons unable to consent, children or members of a subject pool. Data collected for class projects is the student's data and should not be utilized by faculty or instructors without the student's express written permission. Faculty and instructors are not permitted to use class projects as a means of collecting data for their use.

Training Requirements: Supervising faculty or instructors must complete the CITI human subjects protection educational training. The IRB requires that students also complete this training. The IRB requires that students also complete this training. Supervising faculty / instructors are responsible for the ethical conduct of class project research.

Where should I submit my IRB protocol?

Please submit your protocol to the Office of Sponsored Programs, Room E-206, MCB or send them as an email attachment to If you are a student in the online Nursing program, your protocol must be signed off on by your instructor and sent to Professor Patricia Rissmiller who will forward it to the IRB.

IRB Manual and Forms